Philips Gets FDA Clearance To Market MicroDose SI Mammography System

2/28/2013 2:50 PM ET

Royal Philips Electronics (PHG) said Thursday that it has received 510(k) clearance from the Food and Drug Administration for its MicroDose SI system, the first full-field digital mammography system on the market with the capability to enable future Single-Shot Spectral Imaging applications.

The company said it is working on future software applications like Spectral Breast Density Measurement, which will build upon the MicroDose SI technology.

High breast density is a known risk factor for breast cancer—women with high breast density are four to five times more likely to get breast cancer than women with low breast density1.

As in existing Philips MicroDose systems, MicroDose SI uses unique digital photon-counting technology, which represents a paradigm shift in mammography by enabling clinicians to conduct exams using low radiation dose without compromising image quality. Philips has further advanced that unique technology with Single-Shot Spectral Imaging, which is built upon the fact that breast density is subject to different tissue types and materials that absorb X-rays at various energies. The technology powering the MicroDose SI uses this fundamental behavior of X-rays, allowing clinicians to see more than just a shadow in mammogram images by separating high and low energy X-ray within one single exposure.